FDA Inspection
ITxM Clinical Service - Allegheny Valley HospitalITxM Clinical Service - Allegheny Valley Hospital – FDA Inspection, Mar 24, 2009
Record Details
This FDA Inspection record concerns ITxM Clinical Service - Allegheny Valley Hospital, with an inspection on March 24, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 24, 2009
- Product Type
- Biologics
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ID · 04d61fbc-82bf-4994-9eb7-d7acdde16b7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579263
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of ITxM Clinical Service - Allegheny Valley Hospital
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 17, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for ITxM Clinical Service - Allegheny Valley Hospital
- FDA Inspection 925320 - 2015-05-05
- FDA Inspection 820618 - 2013-02-26
- FDA Inspection 697238 - 2010-11-17
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